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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enroll. PAS for Liposorber LA-15 Sys


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General
Application Number H120005 / PAS001
Current Plan Approved 02/19/2016
Study Name OSB Lead-New Enroll. PAS for Liposorber LA-15 Sys
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multicenter, single arm study with a total of 35 newly enrolled patients, treated at 3 to 10 clinical centers in the United States. The primary objectives of this study are to evaluate the safety and probable benefit of the Liposorber LA-

15 System in relieving nephrotic syndrome associated with refractory pediatric primary FSGS at 1 month after the final apheresis treatment.

Study Population Description Pediatric patients with nephrotic syndrome associated with

primary focal segmental glomerulosclerosis, when the standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, have been unsuccessful or not well tolerated, and the patient has a GFR ¡Ý 60 ml/min/1.73m2, or the patient is post renal transplantation.

Sample Size A total of 35 patients will be included.

The primary probable benefit endpoint will be assessed using a

95% confidence interval. The assumption for sample size calculation was that 50% of patients would achieve a 50% reduction in urine protein at 1 month. Optimal conservative medical therapy would be expected to be approximately 10% based on the collected data in Glomerular Disease Collaborative Network (University of North Carolina, Chapel Hill, NC). The reported clinical results in pediatric steroid- resistant FSGS treated with the Liposorber® LA-15 System

suggest the incidence of favorable cases is at least 25%, implying that the probable benefit of the system is superior to that of ordinary medical therapies. With a performance goal of

25%, an expected rate of 50% of patients, a one-sided exact binomial test, and a type I error rate of 0.025 (corresponding to a 95% one-sided confidence interval), 30 patients provides a power of 0.82.

Data Collection The primary probable benefit endpoint is the percent of

patients who show complete or partial remission at 1 month after the final apheresis treatment.

The primary safety endpoint is the rate of device-related and procedure-related serious adverse events (SAEs) occurring during the period in which the apheresis procedures are administered and up to at the 1-month follow-up visit. Secondary endpoints are as follows:

- Nephrotic condition (complete remission, partial remission, and nephrotic state) at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including the percentage of patients who obtain complete or partial remission at 3, 6, 12, and 24 months

- Incidence of adverse events encountered during the period in which apheresis treatments are given

- Incidence of all AEs and SAEs occurring within 3, 6, 12, and 24 months after the final apheresis treatment

- Laboratory values, including eGFR, at baseline, after the last treatment, and at 1, 3, 6, 12, and 24 months after the final apheresis treatment, including percent change from baseline and percentage of patients showing an increase or decrease in each value

Follow-up Visits and Length of Follow-up Patients will be followed for 24 months after they complete the apheresis procedures.

Study visits will be as follows: Pre-procedural exams and test, approximately 9 weeks of study apheresis procedures, and 1-, 3-, 6-, 12- and

24-month follow-up office visits.


OSB Lead-New Enroll. PAS for Liposorber LA-15 Sys Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/10/2014 07/08/2014 Overdue/Received
one year report 10/10/2014 10/02/2014 On Time
18 month report 04/10/2015 04/06/2015 On Time
two year report 10/10/2015 10/01/2015 On Time
three year report 10/09/2016    
four year report 10/09/2017    
five year report 10/09/2018    
six year report 10/09/2019    
Final Report 01/09/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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